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Abstract
Background:
The optimal immunosuppressive strategy for renal transplant recipients at high immunological risk requires clarification. We compared the 3 year outcomes of a sirolimus group (tacrolimus plus sirolimus) to those of a control group (tacrolimus plus mycophenolate mofetil).
Methods:
This observational study was an extension of a prospective pilot study. We assessed acute rejection, glomerular filtration rate, adverse events, graft, and patient survival.
Results:
Overall, 43% of the sirolimus group versus 78% of the control group were still on the initial immunosuppressive regimen at 3 years (P=0.005), and most discontinuations in each group were due to adverse events. No differences were observed between two groups with respect to acute rejection. The mean glomerular filtration rate at 36 months was greater in the sirolimus group than in the control group, but this was not statistically significant (64.0±16.8 mL/min/1.73 m2 vs. 61.8±17.1 mL/min/1.73 m2, P=0.576). Graft and patient survival were similar in both groups. Importantly, mean tacrolimus through levels were significantly lower in the sirolimus group than in the control group at each time point. No neoplasm was reported in the sirolimus group. In the control group, three cases of neoplasms developed during the study period.
Conclusions:
The sirolimus group had a greater number of discontinuations, particularly related to adverse events. Nevertheless, optimal concentration of sirolimus allowed reduced calcineurin inhibitor exposure in high immunologic risk patients, without increasing the risk of acute rejection and graft failure.
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Fig. 2.
Immunosuppressive protocol. Abbreviations: SRL, sirolimus; TAC, tacrolimus; MMF, mycophenolate mofetil.
Fig. 3.
Change in mean estimated glomerular filtration rates between study groups. Abbreviation: eGFR, estimate glomerular filtration rate.
Fig. 4.
Mean study drug trough levels during the study period. (A) Tacrolimus. (B) Sirolimus. aP＜0.05.
Table 1.
Baseline characteristics
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